Kornimate/medical-research-clean huggingface dataset:
a comparative study on the effectiveness of video vs text-based education in heart failure

Conditions: Heart Failure

Summary: this is a study seeking to compare the change in overall heart failure (hf) knowledge score and participant preference between video-based and text-based hf education modules. participants will be randomized to watching and reading different combinations of video-based education modules and text-based education modules. participants will be asked to answer questions about their familiarity with heart failure medications and management before and after the said education modules.

this study compares the change in heart failure (hf) knowledge and participant preference between video-based and text-based hf education modules. educational material regarding two different topics - heart failure self-monitoring and medication management - has been developed in two different formats: animated educational videos and text-based documents. both formats contain the same information. in this study, participants will be randomized to either watching or reading different combinations of the education for these two topics to better understand which educational tool - animated videos or text-based - is preferred by participants and leads to greater educational attainment. educational attainment is evaluated by pre and post questions about both topics.

Eligibility criteria:
inclusion criteria: * participants with heart failure with reduced ejection fraction (ef \<50%) exclusion criteria: * participants who have the inability to independently read or answer written questions in english and are non-conversant in english

Keywords: heart failure education
immunogenicity of hepatitis b vaccination in methadone maintenance treatment patients

Conditions: Hepatitis B Vaccine

Summary: this is a randomized, controlled trial. the study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis b vaccine with three injections at months 0, 1, and 6 in methadone maintenance treatment patients.

comparison of 2 vaccination strategy against hepatitis b in patients with methadone maintenance treatment intervention: arm 1 : 60 µg recombinant hepatitis b vaccine with three injections at months 0, 1, and 6; arm 2 : 20 µg recombinant hepatitis b vaccine with three injections at months 0, 1, and 6.

Eligibility criteria:
inclusion criteria: * aged between 18 and 70 years at the enrolment * serologically negative for hepatitis b surface antigen (hbsag) and hepatitis b surface antibody (anti-hbs) at enrollment * willing to adhere to the study protocol exclusion criteria: * being pregnant * intolerance or allergy to any component of the vaccine * any vaccination during the month preceding enrollment * ongoing opportunistic infection * liver disease * hematological disorder * cancer * unexplained fever the week before enrollment

Keywords: hepatitis b, vaccine immunogenicity methadone maintenance treatment randomized controlled trial
usability study to assess the reveal linq insertable cardiac monitor system

Conditions: Syncope; Recurrent Symptomatic Atrial Fibrillation

Summary: the purpose of the reveal linq usability study is to assess the functionality of the reveal linq insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor

the reveal linq usability study is a prospective, non-blinded, non-randomized, multi-center clinical trial. subjects will transmit device data via manual interrogation on a weekly basis during the first month and will be evaluated in the office at 1-month post-implant, in addition to an automatic nightly wireless data transmission using the mycarelink® home monitor. all subjects will be requested to wear an external holter for 48 hours at approximately 4 weeks post-insertion. follow-up visits will continue at 6 and 12 months post-implant, with monthly manual interrogations. subjects will be exited at their 12 month follow-up visit. the overall study will be conducted in 2 phases which differ primarily on inclusion criteria: phase i subjects (initial 30 subjects) will have any indication for an icm, phase ii subjects (all subjects following the initial 30 subjects) will be atrial fibrillation (af) pre-ablation patients. the study will assess functionality of the reveal linq device by assessing sensing performance and data transmission.

Eligibility criteria:
inclusion criteria: * subject is willing to sign and date the consent form. * subject is indicated for a reveal device within the existing market approved indications * phase i (initial 30 subjects): any indication for a reveal linq device * phase ii (after the initial 30 subjects): subject has atrial fibrillation and is indicated for and identified as an af pre-ablation candidate\* \*note: atrial fibrillation must be documented in the subject's medical history. * subject has a life expectancy of 18 months or more. * subject is willing and able to set up and utilize mycarelink® home monitor and be remotely monitored (i.e., medtronic carelink® network) * subjects who are female of childbearing potential (last menses less than 1 year prior to enrolment) must: * have a negative pregnancy test at enrollment. * not be breastfeeding. * either be surgically sterile, postmenopausal (cessation of menses for at least 1 year), or agree to use a medically accepted, highly effective method of contraception during the entire duration of the study. exclusion criteria: * subject has an active implanted cardiac medical device (e.g., ipg, icd, crt, etc). * subject is unwilling or unable to comply with the study procedures * subject is legally incapacitated and unable to provide written informed consent. * any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological diagnosis) * patient is enrolled in another study that could confound the results of this study, without documented pre-approval from medtronic study manager. * local law prohibits participation (e.g., minor status as specified by local law)
to study the effects of aliskiren on albuminuria and various biomarkers in patients with nephropathy

Conditions: Non-diabetic Nephropathy

Summary: the study is designed to primarily assess the effect of aliskiren on albuminuria in patients with non-diabetic nephropathy when treated with ramipril and volume intervention.


Eligibility criteria:
inclusion criteria: * male and female subjects, age 18 years and above * patients with chronic kidney disease of non-diabetic origin * glomerular filtration rate \>30 ml/min/1.73m2 * patients with a history of hypertension and mssbp (mean systolic blood pressure) of \<160 mm hg and msdbp (mean diastolic blood pressure) \<105 mm hg at screening and baseline. * subjects must have a body mass index (bmi) within the range of 18 and 35 kg/m2 exclusion criteria: * previously treated (within 3 months of screening) with aliskiren or a combination of aliskiren and ramipril. * severe hypertension (msdbp ≥110 mmhg and mssbp ≥180 mmhg) * pregnant or nursing (lactating) women, * a medical history of unstable coronary artery disease, myocardial infarction, coronary bypass surgery or cerebrovascular accident within the last six (6) months * diabetes mellitus, heart failure * high rate of renal function loss * history of severe hypersensitivity or contraindications to any of the medications or drugs belonging to the similar therapeutic class as the study drugs and the excipients. * history of liver disease, positive hepatitis b surface antigen (hbsag) or hepatitis c test result * history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result. other protocol-defined inclusion/exclusion criteria applied
cardiac arrest extra corporeal oxygenation membrane

Conditions: Cardiac Arrest; Cardiopulmonary Resuscitation; Advanced Cardiac Life Support; Extracorporeal Life Support

Summary: french guidelines for cardio pulmonary resuscitation (cpr) consider extra-corporeal life support (ecls) as one option in refractory out-of hospital cardiac arrest (rohca) patients with a no-flow less than five minutes and absence of spontaneous circulation 30 minutes after initiation of advanced cpr. duration of both pre-cpr arrest (no-flow) and of cpr (low-flow) have been systematically highlighted as crucial prognostic factors in all observational studies focused on rohca. in order to shorten the time to ecls initiation, the most recent european resuscitation council guidelines recommend, in eligible rohca patients, a fast track access to ecls implantation. chru nancy elaborated an operational strategy which was designed to improve the enrolment of eligible rohca patients and to reduce the delay time between recognition and ecls initiation. the objective of the present register was to assess prospectively the impact of this new operational strategy over a 5 years period.


Eligibility criteria:
inclusion criteria: * witnessed out-of-hospital cardiac arrest * in qualified geographical locations * no return of spontaneous circulation (rosc) after 10 min of cpr * no flow \<1 min exclusion criteria: * apparent obvious comorbidities * patient \< 18 yo * pregnancy * patient under protective supervision

Keywords: refractory out-hospital cardiac arrest extracorporeal life support
trajectory analysis of symptom distress and cancer-related fatigue after adjuvant chemotherapy in breast cancer female

Conditions: Symptom Distress During Breast Cancer Treatment

Summary: when receiving adjuvant chemotherapy, a variety of symptoms will appear and it is very painful. these symptoms occur at the same time and are related to each other. the symptom distress may affect the patient's compliance with adjuvant chemotherapy and whether the adjuvant chemotherapy can be completed on schedule. among the symptoms of trouble, cancer-related fatigue is the most common, and the incidence can be as high as 99%. in this study, i want to track the population of breast cancer patients receiving adjuvant chemotherapy, and women in the control group who receive only anti-hormonal breast cancer or carcinoma in situ. during the treatment period, at different time points, it also collects subjective symptom distress changes and changes. the study aimed cancer-related exhaustion is measured to gain a deeper understanding of the effects of symptom troubles suffered by patients during treatment. we also hoped that in the future, it can be provided to colleagues in clinical work and can be given to breast cancer patients receiving adjuvant chemotherapy and increased holistic care quality.


Eligibility criteria:
inclusion criteria: 1. the surgical pathological tissue report confirms that the diagnosis is zero stage breast carcinoma in situ women and stage i\~iii breast cancer women. 2. those who are admitted to the hospital for the first time adjuvant chemotherapy or hormonal therapy. 3. age (inclusive) over 20 years old exclusion criteria: 1. women with breast cancer who are unconscious or unable to express.

Keywords: breast cancer cancer related fatigue symptom distress insomnia chemotherapy
a study of tak-360 in adults with narcolepsy without cataplexy (nt2)

Conditions: Narcolepsy Type 2

Summary: narcolepsy without cataplexy or narcolepsy type 2 (nt2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. people with nt2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. they may have difficulty thinking clearly, paying attention, or remembering things, during the day. these symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. orexin is a chemical made in the brain that helps keep a person awake and alert. tak-360 acts like orexin. previous studies have shown that medicines that act like orexin may keep people awake. the main aim of this study is to learn how safe tak-360 is and how well adults with nt2 tolerate it. researchers also want to find out if tak-360 can help people with nt2 stay awake and determine the right dosage needed to do that. participants will be randomly (by chance, like drawing names from a hat) assigned to get either tak-360 or placebo in the treatment period. the placebo is a pill that looks just like tak-360 but does not have any medicine in it. using a placebo helps researchers learn about the real effect of the treatment.


Eligibility criteria:
key inclusion criteria: 1. the participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (bmi) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\]. 2. the participant has a documented, current diagnosis of nt2. key exclusion criteria: 1. the participant has a current medical disorder associated with excessive daytime sleepiness (eds) other than nt2. 2. the participant has medically significant thyroid disease. 3. the participant has a history of cancer in the past 5 years. (this exclusion does not apply to participants with carcinoma in situ \[such as basal cell carcinoma\] that has been treated and is stable, or who have been stable without further treatment. these participants may be included after approval by the medical monitor). 4. the participant has any of the following viral infections based on a positive test result: hepatitis b surface antigen (at screening), hepatitis c virus (hcv) antibody (at screening), human immunodeficiency virus (hiv) antibody/antigen (at screening). 5. the participant has a clinically significant history of head injury or head trauma. 6. the participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood). 7. the participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Keywords: narcolepsy without cataplexy nt2 tak-360
a study to compare tissue and liquid biopsies in people with different types of cancer

Conditions: Non-Small-Cell Lung Carcinoma; Colorectal Cancer; Pancreatic Ductal Adenocarcinoma

Summary: in study, liquid biopsy samples will be obtained from non-small cell lung cancer (nsclc) including squamous cell carcinoma, adenocarcinoma and large cell carcinoma, colorectal carcinoma (crc) and pancreatic ductal adenocarcinoma (pdac) patients who undergo treatment according to established standards of care (soc) at the university hospital schleswig-holstein (uksh). this study will observe the overall variant allele frequency (vaf) of circulating tumour desoxyribonucleic acid (ctdna) levels over the patient therapeutic treatment course and will correlate these findings with tumour response as well as kirsten rat sarcoma viral oncogene homolog (kras)mutation status.


Eligibility criteria:
inclusion criteria: 1. ≥18 years old 2. male or female patients with pancreatic ductal adenocarcinoma, colorectal carcinoma or adenocarcinoma of the lung as specified above leading to new treatment line. 3. signed and dated written informed consent in accordance with international council on harmonisation-good clinical practice (ich-gcp) and local legislation prior to admission to the study. 4. willingness to undergo pre- and on-treatment liquid biopsies for biomarker assessment. patients can be enrolled without tissue tumour biopsy upon agreement between the investigator and the sponsor. exclusion criteria: 1. patients not expected to comply with the protocol requirements or not expected to complete the study as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable study participant). 2. women who are pregnant or who plan to become pregnant during the study. 3. participation at a clinical trial involving an investigational medicine where the treatment details cannot be disclosed.
luteinizing hormone (lh) supplementation in gonadotropin-releasing hormone (gnrh) antagonist cycles

Conditions: Ovarian Stimulation

Summary: to analyse the impact on cycle outcome of lh supplementation in ovarian stimulation controlled with a gnrh antagonist in two ages groups: patients upto 35 years old, and patients aged between 36 and 39 years old.

all patients received an oral contraceptive pill with 0.030 mg of ethinyl-estradiol and 3.0 mg of drospirenone the cycle prior to ovarian stimulation. on the second day of menstruation, patients started ovarian stimulation as follows: patients \< 36: 225 iu/day of recombinant fsh (fsh alone group) or 150 iu of rfsh and 75 iu of rlh/day (fsh+lh group) for 5 days. on day 6, a 0.25 mg/day dose of the gnrh antagonist cetrorelix is added until the day of rcg administration. patients 36-39: initial dose of 300 iu of rfsh /day (fsh alone group)) or 225 iu of rfsh and 75 iu of rlh/day (fsh + lh group) for 5 days. on day 6, a 0.25 mg/day dose of the gnrh antagonist cetrorelix is added until the day of rcg administration. a maximum of 3 embryos were transferred on day 3 of embryo development.

Eligibility criteria:
inclusion criteria: * 1st-2nd ivf cycle. * age until 39 years old * bmi: 18-29.9. * basal fsh \< 12 iu/l exclusion criteria: * lh:fsh \> 2 (pco) * low response background (\< 5 oocytes) * endometrioma * recurrent pregnancy loss * any preimplantational genetic diagnosis indication * any systemic, metabolic or endocrinological disorder.

Keywords: ovarian stimulation in vitro fertilization luteinizing hormone gnrh antagonist implantation rate in infertile patients undergoing in vitro fertilization and embryo transfer.
post prandial glucose control proof-of-principle

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes 2. between 21 and 75 years of age 3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile 4. bmi is \> 18.5 kg/m2 and \<35 kg/m2 5. hba1c \< 9.0% exclusion criteria: 1. subject uses exogenous insulin, exenatide, or sitagliptin phosphate 2. type 1 diabetes. 3. history of diabetic ketoacidosis. 4. current infection 5. active malignancy 6. has had a significant cardiovascular event or history of congestive heart failure. 7. end-stage organ failure or post organ transplant. 8. history of renal disease. 9. hepatic disease. 10. history of gastrointestinal disorders 11. chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv. 12. taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications 13. clotting or bleeding disorders. 14. allergic or intolerant to any ingredient found in the study products.
polypropylene mesh in prolapse surgery

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study was to report the long-term objective and subjective outcome after prolapse surgery with polypropylene mesh. the complications and the effect of the learning curve of the surgeons to the outcome is also reported.


Eligibility criteria:
195 first patients with pelvic organ prolapse operated on using polypropylene mesh
aurinia renal response in active lupus with voclosporin

Conditions: Lupus Nephritis

Summary: the purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.

the aim of the current study is to investigate whether voclosporin, added to the standard of care treatment in active lupus nephritis (ln), is able to reduce disease activity over a treatment period of 52 weeks. the background therapy will be mycophenolate mofetil (mmf) and initial treatment with iv methylprednisolone, followed by a reducing course of oral corticosteroids. subjects with active, flaring ln will be eligible to enter the study. they are required to have a diagnosis of ln according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis. efficacy will be assessed by the ability of the drug combination to reduce the level of proteinuria (as measured by urine protein creatinine ratio (upcr)) while demonstrating an acceptable safety profile.

Eligibility criteria:
key inclusion criteria: - subjects with evidence of active nephritis, defined as follows: * kidney biopsy result within 2 years prior to screening indicating class iii, iv-s, iv-g (alone or in combination with class v), or class v ln with a doubling or greater increase of upcr within the last 6 months to a minimum of ≥1.5 mg/mg for class iii/iv or to a minimum of ≥2 mg/mg for class v at screening. biopsy results over 6 months prior to screening must be reviewed with a medical monitor to confirm eligibility. or * kidney biopsy result within 6 months prior to screening indicating class iii, iv-s or iv-g (alone or in combination with class v) ln with a upcr of ≥1.5 mg/mg at screening. or * kidney biopsy result within 6 months prior to screening indicating class v ln and a upcr of ≥2 mg/mg at screening. * women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. exclusion criteria: * estimated glomerular filtration rate (egfr) of ≤45 ml/minute at screening. * current or medical history of: * congenital or acquired immunodeficiency. * in the opinion of the investigator, clinically significant drug or alcohol abuse within 2 years prior to screening. * malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. * lymphoproliferative disease or previous total lymphoid irradiation. * severe viral infection or known hiv infection. * active tuberculosis (tb), or known history of tb/evidence of old tb if not taking prophylaxis with isoniazid. * other known clinically significant active medical conditions, such as: * severe cardiovascular disease, liver dysfunction or chronic obstructive pulmonary disease or asthma requiring oral steroids or any other overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes.

Keywords: lupus nephritis calcineurin inhibitors voclosporin